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FDA 510(k) Application Details - K131881
Device Classification Name
Compressor, Air, Portable
More FDA Info for this Device
510(K) Number
K131881
Device Name
Compressor, Air, Portable
Applicant
TRUDELL MEDICAL INTL.
725 THIRD ST.
LONDON N5V 5G4 CA
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Contact
DARRYL FISCHER
Other 510(k) Applications for this Contact
Regulation Number
868.6250
More FDA Info for this Regulation Number
Classification Product Code
BTI
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More FDA Info for this Product Code
Date Received
06/25/2013
Decision Date
10/24/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K131881
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